Encorafenib (3) – Braftovi®

Non-small cell lung cancer, advanced, BRAF V600E mutation, combination with binimetinib

Characteristics

Start date 01.10.2024 – Marketing authorisation: 29.08.2024
Resolution 20.03.2025
INN Encorafenib
Brand name Braftovi®
Pharm. company Pierre Fabre Pharma GmbH
G-BA Procedure ID D-1114
ATC code L01EC03 BRAF inhibitors (L01EC)
ICD-10 codes (AIS) C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung
Alpha-ID codes (AIS) I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas
Therapeutic area Oncological diseases Non-small-cell lung carcinoma (NSCLC)
Reason for procedure New therapeutic indication
Specialty ACT change Combination therapy

Therapeutic indication of the resolution

Encorafenib in combination with binimetinib is used in adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
Subpopulation Indication Comparator
a) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and a BRAF V600E mutation; first-line therapy - Dabrafenib in combination with trametinib or – pembrolizumab as monotherapy or – Atezolizumab as monotherapy or – Cemiplimab as monotherapy or – Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (only for patients with ECOG PS 0-1) or – Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin (only for patients with ECOG PS 0-1) – Atezolizumab in combination with nab-paclitaxel and carboplatin (only for patients with ECOG PS 0-1) – Cemiplimab in combination with platinum-based chemotherapy (only for patients with ECOG PS 0-1) – Durvalumab in combination with tremelimumab and platinum-based chemotherapy (only for patients with ECOG PS 0-1)
b) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% and a BRAF V600E mutation; first-line therapy - Dabrafenib in combination with trametinib or – Pembrolizumab in combination with pemetrexed and platinum-containing chemotherapy (only for patients with ECOG PS 0-1) or – Atezolizumab as monotherapy (only for patients with PD-L1 expression ≥ 10% in tumour-infiltrating immune cells) or – Atezolizumab in combination with bevacizumab, paclitaxel and carboplatin (only for patients with ECOG PS 0-1) or – Atezolizumab in combination with nab-paclitaxel and carboplatin (only for patients with ECOG PS 0-1) or – Nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy (only for patients with ECOG PS 0-1) – Cemiplimab in combination with platinum-based chemotherapy (only for patients with ECOG PS 0-1) – Durvalumab in combination with tremelimumab and platinum-based chemotherapy (only for patients with ECOG PS 0-1)
c) Adults with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation; after first-line therapy Dabrafenib in combination with trametinib

Studies and Results

No. of studies
(best subpopulation) 		1 (PHAROS) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + no comparison)
Reason for dividing into subpopulations (G-BA) Previous treatment, Disease stage
ACT change 27.08.2024 – Neuer wissenschaftlicher Standard

  • Clinical trials
    • The PHAROS Phase II trial – which is currently ongoing, open-label, multicentre and single-arm – enrolled patients with metastatic NSCLC harbouring a BRAF V600 mutation – 59 patients in the first-line setting and 39 previously treated patients.

a) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and a BRAF V600E mutation; first-line treatment

  • The additional benefit is not proven.
  • As the single-arm PHAROS trial does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.

b) Adults with advanced non-small cell lung cancer (NSCLC) with PD-L1 expression < 50% and a BRAF V600E mutation; first-line treatment

  • The additional benefit is not proven.
  • As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.

c) Adults with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation; following first-line treatment

  • The additional benefit is not proven.
  • As the single-arm PHAROS study does not allow for a comparison with the appropriate comparator therapy in any of the three patient groups, no evaluable data are therefore available.
  • Conclusion
    • Consequently, the G-BA concludes that an additional benefit is not proven for encorafenib in combination with binimetinib in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring a BRAF V600E mutation.

Courtesy translation only, please refer to the German original.

Associated procedures



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